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A Trial of SHR-1701 in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04324814
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Atridia Pty Ltd.

Tracking Information
First Submitted Date  ICMJE November 28, 2019
First Posted Date  ICMJE March 27, 2020
Last Update Posted Date September 1, 2021
Actual Study Start Date  ICMJE March 24, 2020
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • Adverse events [ Time Frame: Screening up to study completion, an average of 1 year ]
    Number of subjects with adverse events (AEs)
  • Laboratory results [ Time Frame: Screening up to study completion, an average of 1 year ]
    Number of subjects with laboratory tests findings of potential clinical importance
  • Vital signs [ Time Frame: Screening up to study completion, an average of 1 year ]
    Incidence of vital sign abnormalities
  • Electrocardiogram [ Time Frame: Screening up to study completion, an average of 1 year ]
    Number of subjects with clinically significant abnormal ECG QT Interval
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • Pharmacokinetic - Cmax [ Time Frame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 ]
    Maximum observed plasma concentration (Cmax) of SHR-1701
  • Pharmacokinetic - AUC∞ [ Time Frame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 ]
    Area under the concentration-time curve from time 0 to infinity of SHR-1701
  • Pharmacokinetic - Tmax [ Time Frame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 ]
    Time to Cmax of SHR-1701
  • Pharmacokinetic - CL/F [ Time Frame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 ]
    Apparent clearance of SHR-1701
  • Pharmacokinetic - Vz/F [ Time Frame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 ]
    Apparent volume of distribution during terminal phase of SHR-1701
  • Pharmacokinetic - t1/2 [ Time Frame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15 ]
    Terminal elimination half-life
  • Pharmacodynamics- ADA [ Time Frame: Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17 ]
    Anti-drug antibody of PD-L1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of SHR-1701 in Subjects With Advanced Solid Tumors
Official Title  ICMJE A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects With Advanced Solid Tumors
Brief Summary This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with advanced solid tumors.
Detailed Description This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase 1 study of repeated doses of SHR-1701 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Dose escalation is designed according to a modified 3+3 scheme, in which 3 to 6 subjects will be enrolled in each dose group. Four dose levels of SHR-1701 are planned. After completion of dose escalation, selected cohort(s) will be expanded.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE Drug: SHR-1701
Anti-PD-L1/TGFβ fusion protein
Study Arms  ICMJE
  • Experimental: Dose level 1
    Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
    Intervention: Drug: SHR-1701
  • Experimental: Dose level 2
    Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
    Intervention: Drug: SHR-1701
  • Experimental: Dose level 3
    Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
    Intervention: Drug: SHR-1701
  • Experimental: Dose level 4
    Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 and Day 15 of each cycle
    Intervention: Drug: SHR-1701
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2020)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed (histologically or cytologically) with solid tumors
  • ECOG Performance Status of 0 or 1 at both the screening and baseline visits
  • Life expectancy ≥12 weeks
  • Adequate laboratory parameters
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Exclusion Criteria:

  • Known history of hypersensitivity to the study drug
  • Prior malignancy active within the previous 2 years
  • Any investigational or concurrent cancer therapy
  • History of immunodeficiency including seropositivity
  • Systemic antibiotics treatment for ≥ 7 days before the first dose
  • A known history of allogeneic organ transplantation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kathy You, PhD +61 02 9299 0433 kathyyou@atridia.com
Contact: Na Li, Pharm.D +8615618362889 na.li@hengrui.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04324814
Other Study ID Numbers  ICMJE SHR-1701-001AUS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Atridia Pty Ltd.
Study Sponsor  ICMJE Atridia Pty Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Atridia Pty Ltd.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP